Lonapegsomatropin Injection

What is this medication?

LONAPEGSOMATROPIN (LOE na peg SOE ma TROE pin) treats growth hormone deficiency. It works by increasing levels of growth hormones in the body. This increases bone and muscle growth. It belongs to a group of medications known as human growth hormones (hGH).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SKYTROFA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Diabetes
• Loud snoring
• Low adrenal gland function
• Low thyroid levels
• Prader-Willi syndrome
• Recent surgery
• Scoliosis
• Sleep apnea
• Vision problems
• An unusual or allergic reaction to lonapegsomatropin, somatropin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. You can take the dose 2 days before or 2 days after the scheduled dosing day; at least 5 days must elapse between doses. Do not take double or extra doses.

What may interact with this medication?

• Certain medications for diabetes, such as glipizide or glyburide
• Estrogen or progestin hormones
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while you are taking this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Your vision may be tested before and during use of this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Burning or tingling sensation in hands or feet
• Diarrhea
• Joint pain
• Lipodystrophy—hardening or scarring of tissue at injection site
• Nausea
• Stomach pain
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze.

Refrigeration (preferred): Store it in the refrigerator. Keep it in the original carton until you are ready to take it. Remove the dose from the carton about 15 minutes before it is time for you to take it. Use the medication within 4 hours of mixing it. If the medication has been mixed for more than 4 hours before using it, get rid of it. Get rid of any unused medication after the expiration date.

Room Temperature: This medication may be stored at room temperature for up to 6 months. Keep it in the original carton until you are ready to take it. If it is stored at room temperature, get rid of any unused medication 6 months after the date it was first removed from the refrigerator, or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.